Pain
Conditions
Interventions
Test group:liposomal bupivacaine
Control group:lidocaine
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 45 years, regardless of gender. 2. Patients clinically diagnosed with unilateral or bilateral knee osteoarthritis meeting the ACR criteria. 3. Refractory symptoms in the target knee (defined as the side with the higher WOMAC pain score) after physical therapy and NSAIDs pharmacotherapy. 4. Candidates scheduled for intra-articular infusion therapy. 5. Voluntary provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. History of local anesthetic toxicity reactions. 2. Prior history of knee surgery. 3. Patients with post-traumatic osteoarthritis. 4. Age > 65 years. 5. Concomitant severe hepatic or renal dysfunction. 6. Receipt of intra-articular therapies (IATs) within one month prior to enrollment. 7. Presence of any concomitant rheumatic diseases. 8. Diabetic vascular disease patients. 9. Declined participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events of Special Interest within 1 Week Post-Intra-articular injection Therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dynamic changes in VAS score from baseline within 2 weeks post-intra-articular injection therapy;Change in WOMAC pain score from baseline at 1 week post-intra-articular injection therapy;Change in WOMAC pain score from baseline at 2 weeks post-intra-articular injection therapy;Incidence of treatment-emergent Adverse Events of Special Interest (AESI) within 2 weeks post-intra-articular injection therapy; | — |
Countries
China
Contacts
Public ContactHongyi Zhu
Shanghai Sixth People's Hospital
Outcome results
None listed